Ischemic StrokePhase 2NCT03202147
Safety and Efficacy of ALZT-OP1a as Adjuvant Treatment in Subjects With Post-Ischemic Stroke Cognitive Impairment (PSCI)
A Phase 2 study testing Cromolyn in people with Ischemic Stroke and Post-stroke Cognitive Impairment, run by AZTherapies, Inc..
Trial summary
This is a Phase II, randomized, double-blinded, placebo-controlled study for subjects with evidence of PSCI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Post-stroke Cognitive Impairment
- What is being tested?
- Cromolyn
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18 years or above;
- Subject has suffered a recent (within 1-7 days) ischemic stroke supported by CT scan or MRI findings;
- Subject has a score on the NIHSS of 5-14 (inclusive);
- Evidence of stroke related cognitive impairment, documented by neuropsychological evaluation and a Clinical Dementia Rating (Global) ≥ 0.5;
- Must be fluent in the language of the cognitive testing material being administered;
- Study partner is available who has frequent contact with the participant (e.g. an average of 10 hours per week or more), and can accompany the participant to all clinic visits for the duration of the protocol;
- Visual and auditory acuity adequate for neuropsychological testing.
Who cannot join
- Subject has medical history of dementia (prior to current ischemic stroke event);
- Subject has a known medical history of major depression or psychotic disorder;
- Unstable cardiovascular or cerebrovascular disease;
- Aphasia or other disability severe enough to prevent valid neuropsychiatric assessment;
- History of any other significant neurological disease prior to ischemic stroke;
- History of schizophrenia or bipolar disorder (DSM-IV criteria);
Show all 18Show fewer
- History of alcohol or substance abuse or dependence within the past 3 years (DSM-IV criteria);
- Currently taking medications that could lead to difficulty complying with the protocol;
- Investigational agents are prohibited one month prior to entry and for the duration of the trial;
- Currently taking cromolyn, or has taken cromolyn, within the past 12 months;
- Allergy to cromolyn (also known as Intal®, Nasalcrom®, Opticrom®, Gastrocrom®, etc.);
- Clinically significant respiratory disorders with impaired respiratory effort or difficulty taking inhaled drugs (examples: Stage III-IV chronic obstructive pulmonary disease [COPD], emphysema);
- Uncontrolled chronic asthma;
- Taking inhaled protein products on a chronic basis (such as insulin, parathyroid hormone [PTH], etc.);
- Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol;
- Pregnancy or lactation for female subjects of child-bearing potential (i.e., < two years post-menopausal or not surgically sterile);
- For sexually active male subjects, unwillingness or incapability of using appropriate contraception methods;
- Severe renal or hepatic impairment.
About this study
Official title: A Phase II Safety and Efficacy Study of ALZT-OP1a as Adjuvant Treatment in Subjects With Post-Ischemic Stroke Cognitive Impairment (PSCI)
This is a Phase II, randomized, double-blinded, placebo-controlled study for subjects with evidence of PSCI.
Read the detailed description
This Phase II study is designed as a randomized, double-blinded, placebo-controlled study for subjects with evidence of PSCI.
Subjects will be randomly assigned to the Group I arm (ALZT-OP1a adjuvant treatment), which will consist of ALZT-OP1a for inhalation, taken twice daily (morning and evening), OR the Group II placebo arm, which will consist of inhaled placebo, taken twice daily (morning and evening).
A minimum of 350 subjects will be randomized to receive one of two possible treatment assignments: ALZT-OP1a adjuvant treatment of active study drug or placebo.
To account for subject dropouts (estimated rate of 30%), it is anticipated that up to 500 (or 250 subjects per treatment arm) may be recruited and randomized, to achieve a minimum of 175 evaluable subjects per treatment arm.
Randomization assignments will be stratified by site to ensure balance by site.
- Conditions
- Ischemic Stroke, Post-stroke Cognitive Impairment
- Being tested
- Cromolyn, Placebo
- Keywords
- Ischemic stroke, post-stroke cognitive impairment, PSCI
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CromolynDrug
Also called Cromolyn sodium
Active capsules for inhalation.
PlaceboOther
Non-active capsules for inhalation.
| Study group | Role | What they receive |
|---|---|---|
| ALZT-OP1a | Active comparator | ALZT-OP1a: cromolyn (17.1 mg, capsule) for oral inhalation via dry powder inhaler, taken twice per day (morning and evening), 8-12 hours apart. Receives: Drug: Cromolyn |
| Placebo | Placebo comparator | ALZT-OP1a: placebo capsule for oral inhalation via dry powder inhaler, taken twice per day (morning and evening), 8-12 hours apart. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MoCA)
The primary endpoint is the difference in performance in the ALZT-OP1a adjuvant treatment group compared to the placebo group, as quantified by the mean change from baseline to Week 12 scored on MoCA.
Measured: Baseline and Week 12
Secondary outcomes (1)
Mini Mental State Examination (MMSE)
The secondary endpoint is the difference in performance in the ALZT-OP1a adjuvant treatment group compared to the placebo group, as quantified by the mean change from baseline to week 12 in points scored on MMSE.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study startDec 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: Study halted prematurely prior to initiation but potentially will resume in the future.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AZTherapies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David A. Brazier, BS, Study director, AZTherapies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202147
- Sponsor's protocol ID
- AZT-003
- Status last verified
- Apr 2020
- First submitted
- 26 Jun 2017
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Safety and Efficacy Study of ALZT-OP1a as Adjuvant Treatment in Subjects With Post-Ischemic Stroke Cognitive Impairment (PSCI)
- ClinicalTrials.gov ID
- NCT03202147
- Acronym / sponsor ID
- AZT-003
- Conditions
- Ischemic Stroke, Post-stroke Cognitive Impairment
- Keywords
- Ischemic stroke, post-stroke cognitive impairment, PSCI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study halted prematurely prior to initiation but potentially will resume in the future.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AZTherapies, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II, randomized, double-blinded, placebo-controlled study for subjects with evidence of PSCI.
Detailed description
This Phase II study is designed as a randomized, double-blinded, placebo-controlled study for subjects with evidence of PSCI.
Subjects will be randomly assigned to the Group I arm (ALZT-OP1a adjuvant treatment), which will consist of ALZT-OP1a for inhalation, taken twice daily (morning and evening), OR the Group II placebo arm, which will consist of inhaled placebo, taken twice daily (morning and evening).
A minimum of 350 subjects will be randomized to receive one of two possible treatment assignments: ALZT-OP1a adjuvant treatment of active study drug or placebo.
To account for subject dropouts (estimated rate of 30%), it is anticipated that up to 500 (or 250 subjects per treatment arm) may be recruited and randomized, to achieve a minimum of 175 evaluable subjects per treatment arm.
Randomization assignments will be stratified by site to ensure balance by site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALZT-OP1a | Active comparator | Drug: CromolynALZT-OP1a: cromolyn (17.1 mg, capsule) for oral inhalation via dry powder inhaler, taken twice per day (morning and evening), 8-12 hours apart. |
| Placebo | Placebo comparator | Other: PlaceboALZT-OP1a: placebo capsule for oral inhalation via dry powder inhaler, taken twice per day (morning and evening), 8-12 hours apart. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, aged 18 years or above;
- Subject has suffered a recent (within 1-7 days) ischemic stroke supported by CT scan or MRI findings;
- Subject has a score on the NIHSS of 5-14 (inclusive);
- Evidence of stroke related cognitive impairment, documented by neuropsychological evaluation and a Clinical Dementia Rating (Global) ≥ 0.5;
- Must be fluent in the language of the cognitive testing material being administered;
Key exclusion criteria (18 listed)
- Subject has medical history of dementia (prior to current ischemic stroke event);
- Subject has a known medical history of major depression or psychotic disorder;
- Unstable cardiovascular or cerebrovascular disease;
- Aphasia or other disability severe enough to prevent valid neuropsychiatric assessment;
- History of any other significant neurological disease prior to ischemic stroke;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CromolynAlso: Cromolyn sodiumActive capsules for inhalation. | Drug | ALZT-OP1a |
| PlaceboNon-active capsules for inhalation. | Other | Placebo |
Primary outcome
Montreal Cognitive Assessment (MoCA)
Time frame: Baseline and Week 12
The primary endpoint is the difference in performance in the ALZT-OP1a adjuvant treatment group compared to the placebo group, as quantified by the mean change from baseline to Week 12 scored on MoCA.
1 secondary outcome
Mini Mental State Examination (MMSE)
Time frame: Baseline and Week 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A. Brazier, BS study director
AZTherapies, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cromolyn in people with Ischemic Stroke and Post-stroke Cognitive Impairment, run by AZTherapies, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (MoCA) (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.